Indiana University Gastric Electrical Stimulation Registry

NCT ID: NCT05047289

Last Updated: 2024-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-20

Study Completion Date

2030-10-20

Brief Summary

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The purpose of this study is to develop a clinical registry in patients with Gastric Electrical Stimulation (GES) therapy for gastroparesis to support future gastrointestinal therapies, medical procedures and diagnostics.

Detailed Description

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This study will evaluate male and female patients at least 18 years of age, with gastroparesis, who will or have already undergone the implantation of a GES device

The study will be conducted at one center and approximately 1,000 subjects will be enrolled.

Subjects undergoing the GES implantation will be enrolled before the implantation and may have a baseline visit. The visit procedures will be conducted at the discretion of the investigator dependent on the clinical condition of the patient at that time.

Conditions

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Gastroparesis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patients undergo implantation of a new GES device for medical refractory gastroparesis

Exclusion Criteria

* Non-ambulatory patients: bed-ridden, nursing home resident, etc.
* Pregnancy
* Unable to give own informed consent.
* Prisoners
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Purdue University

OTHER

Sponsor Role collaborator

Indiana University

OTHER

Sponsor Role lead

Responsible Party

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John M. Wo

Director, GI Motility and Neurogastroenterology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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John Wo, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University School of Medicine

Locations

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Indiana University Hospital

Indianapolis, Indiana, United States

Site Status

Countries

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United States

Other Identifiers

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2008529997

Identifier Type: -

Identifier Source: org_study_id

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